TECNIS IOL ZMB00 (REF ZMB00U0245)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 1- PIECE 6.0MM 24.5 US · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474535718), received between Dec 28, 2016 and Nov 19, 2019 — classified as 2 injuries.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Visual Disturbances2
- Foreign Body Reaction1
- No Code Available1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED POST IMPLANT OF A MODEL ZMB00 INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED GLARE. THROUGH FOLLOW UP, IT WAS LEARNED THE PATIENT IS STILL UNHAPPY AND IS SEEING STREAKS OR FIRECRACKERS AND GLARE AT NIGHT. GLASSES WERE PRESCRIBED FOR MILD ASTIGMATISM AND WITH ANTI-GLARE COATING WITHOUT MUCH IMPROVEMENT IN SYMPTOMS. VISUAL ACUITY PRE-OPERATIVE 20/40 AND BEST CORRECTED VISUAL ACUITY (BCVA) POST-OPERATIVE 20/30. THE PATIENT HAS BEEN REFERRED TO A RETINA SPECIALIST FOR CONSIDERATION OF IOL REMOVAL. THE PATIENT DOES NOT WISH TO HAVE ANOTHER SURGERY. AT THIS TIME, THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available; Visual Disturbances
MAUDE report 9345204 ↗InjuryDec 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INITIALLY, IT WAS REPORTED THAT A FEMALE PATIENT EXPERIENCED SEVERE STARBURST AT NIGHT ((B)(6) 2016) WHILE DRIVING, SHARP PAIN IN EYE AND SENSATION OF DEBRIS IN EYE AFTER IMPLANTATION OF AN ABBOTT PRODUCT FOR 1 MONTH. DURING A FOLLOW UP, CUSTOMER PROVIDED SERIAL NUMBERS (B)(4) IMPLANTED IN PATIENT'S EYES. REPORTEDLY, RIGHT EYE LENS WAS IMPLANTED ON (B)(6) 2016 AND LEFT EYE LENS WAS IMPLANTED ON (B)(6) 2016. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT REPRESENTS THE LENS SERIAL NUMBER (B)(4). A SEPARATE REPORT IS BEING FILED FOR THE LENS SERIAL NUMBER (B)(4).
Patient problems: Foreign Body Reaction; Pain; Visual Disturbances
MAUDE report 6207945 ↗
Other LENS, MULTIFOCAL INTRAOCULAR devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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